FDA.report

BARRIER WRAP W/SUPPORT W/TC ULTRAFLEX/BLK/XL

Primary DI
00850035588017
Brand
BARRIER WRAP W/SUPPORT W/TC ULTRAFLEX/BLK/XL
Company
Barrier Technologies, LLC
Model
BWSP-.5mmPbF-XL-UF-BLK
Device description
Barrier Wrap with Support Apron. Provides full wrap around protection against direct & scatter radiation. One-piece design enables easy-on & easy-off. Fully adjustable integrated back support belt provides maximum support to the lower lumbar region. Black UltraFlex material. Size extra large. Thyroid collar included.
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EAJApron, Leaded

Product Code Classifications

CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850035588017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035588017008500355880178500355880170850035588017

GMDN Terms

TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
621134084
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850035588895Barrier Wrap with Support Radiation Protection Apron - Pb Standard - XX-LargeBWSP-PbS-XXL2022-10-13
00850035588901Support Vest & Skirt Radiation Protection Apron - Pb Standard - SmallSPVS-PbS-SM2022-10-13
00850035588918Support Vest & Skirt Radiation Protection Apron - Pb Standard - MediumSPVS-PbS-MD2022-10-13
00850035588925Support Vest & Skirt Radiation Protection Apron - Pb Standard - LargeSPVS-PbS-LG2022-10-13
00850035588932Support Vest & Skirt Radiation Protection Apron - Pb Standard - X-LargeSPVS-PbS-XL2022-10-13
00850035588949Support Vest & Skirt Radiation Protection Apron - Pb Standard - XX-LargeSPVS-PbS-XXL2022-10-13
00850035588956Standard Vest & Skirt Radiation Protection Apron - Pb Standard - SmallSVS-PbS-SM2022-10-13
00850035588963Standard Vest & Skirt Radiation Protection Apron - Pb Standard - Medium SVS-PbS-MD2022-10-13
00850035588970Standard Vest & Skirt Radiation Protection Apron - Pb Standard - Large SVS-PbS-LG2022-10-13
00850035588987Standard Vest & Skirt Radiation Protection Apron - Pb Standard - X-LargeSVS-PbS-XL2022-10-13
00850035588994Standard Vest & Skirt Radiation Protection Apron - Pb Standard - XX-Large SVS-PbS-XXL2022-10-13
00850035588635 Standard Vest & Skirt Radiation Protection Apron - Pb Free - Small SVS-PbF-SM2022-10-12
00850035588642Standard Vest & Skirt Radiation Protection Apron - Pb Free - MediumSVS-PbF-MD2022-10-12
00850035588659 Standard Vest & Skirt Radiation Protection Apron - Pb Free - Large SVS-PbF-LG2022-10-12
00850035588666Standard Vest & Skirt Radiation Protection Apron - Pb Free - Made to Measure SVS-PbF-MTM2022-10-12
00850035588673Standard Vest & Skirt Radiation Protection Apron - Pb Free - X-Large SVS-PbF-XL2022-10-12
00850035588680Standard Vest & Skirt Radiation Protection Apron - Pb Free - XX-Large SVS-PbF-XXL2022-10-12
00850035588697Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - SmallMGF-PbF-SM2022-10-12
00850035588703 Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - MediumMGF-PbF-MD2022-10-12
00850035588710Barrier Flex Radiation Protection Apron w/Magnaguard - Pb Free - LargeMGF-PbF-LG2022-10-12

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